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versão On-line ISSN 2078-5135versão impressa ISSN 0256-9574

SAMJ, S. Afr. med. j. vol.105 no.11 Cape Town Nov. 2015

http://dx.doi.org/10.7196/SAMJ.2015.V105I11.10200

IZINDABA

Motsoaledi on 'tide-turning' new HIV treatment guidelines

Minister of Health Dr Aaron Motsoaledi says that implementing the highly lauded new World Health Organization (WHO) HIV treatment guidelines will require careful fine-tuning to South Africa (SA)'s most vulnerable groups, with some aspects easier to implement than others.

In an exclusive interview with Izindaba he was upbeat and clearly in favour of both the WHO's 'test and treat' recommendation that all HIV-positive people be put on treatment as soon as they are diagnosed, and the recommendation that a pre-exposure prophylaxis (PrEP) pill be made available to all at-risk groups. He nevertheless urged caution, saying that a very clear set of pragmatic policies would need to be thrashed out with the country's top experts at the South African National AIDS Council as a matter of urgency, so that 'we can take everybody with us'.

A 'test and treat' policy would be a radical departure from SA practice over the past 2 years, where HIV-positive people only qualify for treatment when their condition worsens to a CD4 cell count of 500/uL (previously set at 350/uL). Only HIV-positive pregnant women currently enjoy the benefits of treatment on diagnosis, something that has contributed hugely to the major success in reducing the mother-to-child HIV transmission rate, now estimated at below 2%. In theory, this means that the number of people in SA who currently qualify for antiretroviral treatment (initiation at a CD4 count of 500/uL) could more than double from 3.1 million on ART (measured in July 2015) to the total HIV-positive SA population of 6.4 million. Worldwide, the 15 million who are currently on treatment could increase to all 37 million people living with HIV. In SA, initiating the new measures would lend real weight to the assertion that HIV treatment is now merely another chronic disease, and give non-communicable diseases the attention they deserve.

The UNAIDS global target of 15 million on ART by 2015 has been achieved. The new United Nations goalpost is to get 90% of people who test positive on ART - and then to get 90% of those same people down to an undetectable viral load by 2020. Dr Gilles van Cutsem, Médecins Sans Frontiêres (MSF, Doctors Without Borders) Chief for SA, told Izindaba that most of the 3.1 million South Africans currently on antretroviral therapy commenced treatment during the past 5 years, when Motsoaledi initiated a massive detection and treatment scale-up, redressing the scandalously slow progress made between 2004 and 2009.

The WHO PrEP recommendation is that all people at risk of contracting HIV be given a pill that prevents them from being infected. This is already recommended in the USA, but Motsoaledi said that HIV pandemic profiles differed from country to country, moving quickly to outline some of the local implementation difficulties while strongly rejecting any notion of cost being a barrier to implementation.

MSF started providing HIV treatment to people in developing countries in 2000, and today more than 200 000 people receive treatment through MSF programmes.

Says Motsoaledi: 'The difficult decision to make [regarding PrEP] is around those populations that are vulnerable, even if they are HIV-negative. It's not that difficult when it comes to HIV-positive people ('test and treat'), sex workers (of whom there are an estimated 150 000), and men who have sex with men (MSM) - but I can't just walk into a classroom tomorrow and say to a million or so HIV-vulnerable youths between 15 and 24 that they must start taking PrEP pills - you can only imagine what the response will be.' Singling out the country's sex workers, he said 70% of them were already known to be HIV-positive, making it easier to reach the remaining 30% with PrEP - and easier to treat any of them who had recently seroconverted. It was the general HIV-negative population that was exercising his mind most. He said people who were already HIV-positive would be likely to have health problems at some stage - 'that's not a difficult decision to take, regardless of cost and numbers'.

'But how many HIV-negative people will have that motivation to take treatment every day? For vulnerable women (a subset population most at risk in the 15 - 24 age cohort where HIV/AIDS is still growing), we'd have to design programmes specifically,' Motsoaledi said, adding that nothing was 'cut and dried' in the complex application of the recommendations.

'We'll have to debate and weigh this against other forms of prevention, like education and condoms,' he said. PrEP is seen by treatment advocacy groups as probably the most effective prophylaxis for young women, for whom few HIV prevention options are available, leaving them at the mercy of male whim when it comes to protection. Motsoaledi said that major awareness and education campaigns would have to be devised to accompany roll-outs.

Dr Francois Venter, former head of the Southern African HIV Clinicians Society and Deputy Executive Director of the Wits Reproductive Health and HIV Institute, said it was 'great' that SA was likely to follow the WHO guidelines, 'although we need to sort out PrEP for adolescent girls. Condoms and behaviour lectures clearly are not enough -we've had them for 20 years and new incident infections are still extremely high. It's going to be politically uncomfortable and operationally difficult, but we really need to be urgently thinking about PrEP as part of the prevention package for young girls.'

Keep the funding tap open - and use peer volunteers

Meanwhile, the highly respected global volunteer body at the forefront of HIV/AIDS treatment in SA, MSF, applauded the latest updated treatment guidelines, saying they could 'turn the tide'.

MSF warned that turning the recommendations into reality would require significantly increased donor and government support, especially in HIV-impacted communities, adding that governments and international donor organisations were already 'prematurely' cutting back on their AIDS budgets.

Dr Tom Ellman, director of MSF's Southern Africa Medical Unit, said that while 'test and treat' could turn the tide on HIV, in order for it to work as a tool to control the epidemic it would require 'drastic changes and greatly increased investment'. 'HIV care has to move out of clinics and into the communities with mobilised, empowered and engaged people living with HIV that actually are part of the response. This will need effort and money.'

He said that almost simultaneously with the WHO announcement on 30 September, world leaders at the United Nations agreed to a sustainable development goal to make AIDS 'history' within 15 years. They would now need to show that they were serious about it. 'Nobody's going to end AIDS with business as usual,' he added. The Global Fund to Fight AIDS, TB and Malaria will hold its replenishment conference next year, making it the first real test of donors' commitment to using the best science to treat all people living with HIV and further decrease rates of HIV transmission worldwide.

Founded in 1995, AVAC is a non-profit organisation that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of AIDS vaccines, male circumcision, microbicides, PrEP and other emerging HIV prevention options as part of a comprehensive response to the pandemic.

Some very real red flags

Experience from MSF's HIV programmes shows that over the past ten years, one-third of people who were diagnosed with HIV, but not eligible to start treatment, never returned to the health facility. Offering such individuals treatment as soon as they test positive could substantially reduce the number of people who may never return. Dr Marc Biot, MSF's operational co-ordinator for HIV, said that in order to reach as many people as possible, as soon as possible, simplified models of care and self-management strategies were needed that allowed people to take more control over their own treatment and care.

'It's no longer only a question of when to start people on treatment, but also how to help people stay on treatment for life and to maintain "undetectable" levels of virus in their blood. We need to make sure HIV treatment fits into people's lives better, just like with any other chronic disease in industrialised countries.' Antiretroviral therapy 'on demand' was a wholly new concept in many parts of the world, where people had long been told to wait until they were sick or approaching low CD4 cell counts to begin treatment. Much work was needed to ensure that this guidance was understood and implemented. The recommendation of PrEP for all people at substantial risk replaces previous WHO guidance that focused on MSM and on heterosexual couples in which one partner is HIV-positive and the other negative.

PrEP steps into the gap to protect vulnerable young women

MSF confirmed that, perhaps most importantly, the recommendation vastly expands the likelihood that oral PrEP will be offered to young women, offering them a long-needed prevention option that they can use discreetly, not at the time of sex - a profoundly important development.

Yvette Raphael, a human rights activist who recently completed a year-long project focused on addressing the HIV prevention, treatment, and sexual and reproductive health needs of young SA women, had this to say: 'In SA, many young women have expressed the need for PrEP to be available as an option that will work for them. PrEP can help young women and girls take more control of their sexual and reproductive health rights and be more empowered to control their own sex lives.' Mitchell Warren, AVAC Executive Director, said that the WHO was paving the way for a fundamental shift in the world's response to HIV - abandoning the partial or piecemeal use of antiretroviral medicines in favour of full access for men and women in need. 'Both science and conscience demand that we put these recommendations into effect as quickly as possible.' Carol Njoroge, a rights activist with the Kenya Sex Worker Alliance and a 2015 AVAC Fellow, focused on expanding PrEP access, said that as a woman who has lived with HIV for 15 years 'I know the importance of taking control of all aspects of your life and health. I see that most of the people at high risk of HIV who know about PrEP and how effective it is, want it. There is demand from male, female and transgender sex workers and others at high risk for HIV, and we have PrEP demonstration studies looking at how best to provide PrEP in the real world.' Kenya had developed a 'prevention revolution roadmap', but there's still a lot more needed: clear clinical guidelines, regulatory approval, civil society partnership and funding commitments to make PrEP a reality. Warren stressed that continued research into additional prevention options remained 'critical'. Two efficacy trials of a monthly vaginal ring with a different antiretroviral called dapivirine, phase II trials of two different injectable antiretrovirals, used every two or three months, a phase II daily rectal microbicide gel, ongoing HIV vaccine trials and new passive antibody studies may eventually provide additional options for young people and others at high risk of HIV.